Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00852215
Status:
UNKNOWN
Last Update Posted:
2009-02-26
First Post:
2009-02-25
Brief Title:
Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion COPE Study Long-Term Follow-up Study
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
Brief Summary:
We sought to evaluate the long-term safety and efficacy of drug-eluting stent in large vessels compared with bare metal stent
Detailed Description:
Drug-eluting stent DES has been proved to reduced restenosis rate dramatically compared to bare metal stent BMS However the long-term safety of DES is still uncertain Recent meta-analysis showed that very late stent thrombosis rate was higher in DES group although overall mortality was similar between 2 groups
The safety issue of DES was first suggested in the BASKET-LATE study which compared cobalt chromium alloy BMS VISION Guidant USA with sirolimus- or paclitaxel-coated DES The study showed a significantly higher rate of death or myocardial infarction in the DES group between 7 and 18 month after the procedure BMS 13 DES 49 p001 Moreover benefit to reduce target vessel revascularization was not found and there was even the possibility of late harm in patients treated with DES in large native vessels
We perform a multicenter prospective randomized study comparing paclitaxel-eluting stent with cobalt chromium stent several years originally to see whether major adverse cardiac event is significantly lower in DES compared to thin-strut BMS in the non-complex lesion subset In this article we would like to investigate the 2-year clinical events in DES and BMS groups
The safety issue of DES was first suggested in the BASKET-LATE study which compared cobalt chromium alloy BMS VISION Guidant USA with sirolimus- or paclitaxel-coated DES The study showed a significantly higher rate of death or myocardial infarction in the DES group between 7 and 18 month after the procedure BMS 13 DES 49 p001 Moreover benefit to reduce target vessel revascularization was not found and there was even the possibility of late harm in patients treated with DES in large native vessels
We perform a multicenter prospective randomized study comparing paclitaxel-eluting stent with cobalt chromium stent several years originally to see whether major adverse cardiac event is significantly lower in DES compared to thin-strut BMS in the non-complex lesion subset In this article we would like to investigate the 2-year clinical events in DES and BMS groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None